BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 1222095 · Received November 5, 2008

    Report

    Report Number
    1820334-2008-00621
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 14, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE ANATOMICAL REQUIREMENTS, WARNINGS, PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. THE DEVICE REMAINS IMPLANTED AND NO IMAGES WERE PROVIDED TO ASSIST IN THIS INVESTIGATION. AN INTERNAL CLINICAL REVIEW INDICATED THAT THE EVENT WAS DUE TO PATIENT ANATOMY. HOWEVER, WE HAVE NOTIFIED THE APPROPRIATE INDIVIDUALS AND WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    A MALE UNDERWENT INITIAL AAA REPAIR IN 2008, EMERGENTLY DUE TO RUPTURED ANEURYSM. THE PHYSICIAN PLACED ONE FLEX MAIN BODY AND TWO ILIAC LEG GRAFTS. ON A FOLLOW UP EXAM, THE PHYSICIAN THOUGHT THERE MIGHT BE A TYPE I ENDOLEAK BUT WASN'T SURE, SO GAVE THE PATIENT THE OPTION TO WAIT AND SEE OR TO HAVE PLACEMENT OF ADDITIONAL DEVICE TO EXTEND THE SEAL ZONE. THE PATIENT DECIDED TO HAVE THE ADDITIONAL DEVICE PLACED. THE PHYSICIAN PLACED AN ILIAC LEG EXTENSION THE FOLLOWING MONTH. PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 2109028

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention